NCT05828238招募中早期 1 期
PET Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of tissue distribution of [18F]-DEVD-2
研究概览
简要总结
This is a single arm study to determining the value of apoptotic molecular probe SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily signed informed consent;
- •Age18-70, male or female;
- •Diagnosed with stage 2 or 3 breast cancer
- •Solid tumors、masses larger than 2cm with lymph node metastasis
- •Pathology is HER3+、triple negative patients
- •Patients to be treated with neoadjuvant chemotherapy
排除标准
- •Age greater than or equal to 70 years old
- •Abnormal liver and kidney function (more than five times the normal value)
- •Diagnosis level of breast cancer stage 4 or second time tumor patients
研究组 & 干预措施
[18F]SF-DEVD-2
Experimental
干预措施: [18F]SF-DEVD-2 (Drug)
[18F]SF-DEVD-2
Experimental
干预措施: [18F]-FDG (Drug)
结局指标
主要结局
Evaluation of tissue distribution of [18F]-DEVD-2
时间窗: 7 days
Biodistribution of \[18F\] -DEVD-2 evaluated by the maximum standardized uptake value（SUVmax) in various organs during repeated \[18F\]-DEVD scans will be reported.
次要结局
未报告次要终点
研究者
Chunjing Yu
Director
Affiliated Hospital of Jiangnan University
研究点 (1)
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